Understanding the European Directives & Implementing the Guidelines

 

Understanding the European Directives & Implementing the Guidelines

Regulatory Courses
Part of Star Programme

European legislation is often far away from daily life, yet during this course you receive all necessary information in a very practical way. You get the ins and outs on several legislations, such as the clinical trial directive, showing the consequences for you. Europe will have no more secrets!

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26 Apr 2012 Brussels English
750,00 €
  • Full description & trainer
  • Programme highlights
  • Learning objectives
  • Workshops & extras
Full description

This one-day course is designed to provide a clear understanding of the regulatory requirements for Clinical Trials in Europe. Essentials of EU Directives 2001/20/EC and 2005/28/EC are explained and the state-of-the-art regarding implementation and implications in the European member states will be presented.
Other topics are the European regulation on Safety Reporting, guidelines concerning Non-Investigational Medicinal Products, instructions for non-commercial clinical trials as well as Regulation (EC) N° 1901/2006 on medicinal products for paediatric use. Interactive presentations are included
to provide a better understanding of the implementation of these requirements and guidance documents in practice.

Who should attend?

Everyone involved in clinical research including: pharmaceutical companies, Contract Research Organisations (CROs), investigators, site personnel and ethics committee members.
People from clinical research, regulatory affairs and pharmacovigilance departments within the pharmaceutical industry.

Trainers
  • Review of key areas of the directives and implementing texts
  • Clinical trial authorization from ethics committees and authorities
  • Update on current guidance documents, Trial Master File and archiving
  • Safety reporting & GCP inspections
  • Upcoming regulations and developments
  • Understand the European directives 2001/20/EC and 2005/28/EC
  • Comprehend the up-to-date implementation in each EU member state
  • Understand the European Regulation 1901/2006/EC on medical products for paediatric use
  • Know the procedure to be compliant and reach successful implementation
Workshops
  • Application forms for EC and authorities in practice
  • How to process SUSARs